Sr Quality Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Location: Marietta, OH.

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

When you're part of the team at Thermo Fisher Scientific, you'll do important work. And you'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Discover Impactful Work:

As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer.

A Day in the Life:

• Manage quality assurance and quality control teams while building strong partnerships with operations, R&D, commercial teams, and customers.
• Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches.
• Maintain inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements.
• Support quality initiatives that deliver consistent product excellence while meeting business objectives.
• Develop quality professionals, lead investigations, and implement data-driven solutions that enhance quality systems and customer satisfaction.

How Will You Get Here?

Education:

• Minimum Education Required: Bachelor's Degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)
• Professional certifications desired (ASQ, Lean Six Sigma, etc.)

Experience:

• Experience Required: 8 years of operations, manufacturing or continuous improvement experience
• Experience in pharmaceutical, medical device, or regulated life sciences industry preferred
• 5+ years of quality management/leadership experience
• Demonstrated experience leading quality investigations, CAPA, and change control processes
• Experience implementing continuous improvement initiatives
• Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
• Experience hosting regulatory inspections and customer audits

Knowledge, Skills, Abilities:

• Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
• Excellent ability to be flexible, adaptable, work in fast paced environment, and be proactive
• Strong understanding of quality management systems and GMP requirements
• Excellent project management and cross-functional leadership abilities
• Strong data analysis and problem-solving capabilities
• Excellent written and verbal communication skills
• Ability to build collaborative relationships at all levels
• Proficiency with quality management software systems
• Ability to travel up to 25%

Benefits

We offer competitive compensation, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 140,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.